Calliditas Therapeutics: A Case Study of Strategic Investment and Successful Exit by Industrifonden

In the mid-1990s, business entrepreneurs Mikael Bender and Bengt Julander founded Pharmalink, laying the foundation for what would eventually become Calliditas Therapeutics. Industrifonden recognized the potential and initially invested SEK 20 million through a convertible loan, turning into a 10% equity stake and setting the stage for a deeper involvement.

The entrepreneurs acquired several different projects from Pharmacia, leveraging their expertise to identify assets and to secure attractive terms. Ultimately, the company decided to focus on a project that would evolve into TARPEYO®, the lead product for Calliditas. TARPEYO is a delayed-release capsule delivering budesonide to the ileum to downregulate Gd-IgA1 antibodies which are at the origin of a rare autoimmune kidney disease known as IgA nephropathy (IgAN), which in many patients lead to chronic kidney failure. The focus of the company was clear – to create innovative treatments for renal and other rare diseases.

As the company developed, Industrifonden played an instrumental role in its financing and increased its ownership stepwise to 33%. The fund also facilitated involvement from additional investors.

In 2017, the company appointed Renée Aguiar-Lucander as CEO, whose business building and financial skills proved instrumental. Under her leadership, Calliditas attracted substantial investments from US funds such as BVF and Vivo Capital.

The company listed on the OMX in 2018 and in 2020 the company also did a dual listing on the US market with the intent to broaden its investor base and establish itself as a locally regulated entity for its potential future US launch. Calliditas also succeeded in securing major partnering deals, selling regional rights to Everest Medicines in China, STADA in the EU and Viatris in Japan. These agreements secured upfront payments of SEK 150-200 million each.

Calliditas retained the US rights and focused on the US market which generally represents more than 60% of the market potential for novel drugs. The company achieved the very first accelerated regulatory approval in IgAN from the FDA in December of 2021 for its lead drug TARPEYO. The pioneering work conducted by the company to be able to use a novel surrogate marker for regulatory approval and market launch was a key factor in the success. 

In December 2023, Calliditas received full FDA approval for its drug TARPEYO for the reduction of loss of kidney function for patients with primary IgAN. The company had by then built a full-fledged US commercial organization which was driving rapid sales growth in 2023-2024.

In 2023, revenues reached 1.2 billion SEK, with analysts projecting growth of more than 50% in 2024, reaching 1.8 billion SEK. In May 2024, Japanese company Asahi Kasei made a cash offer of 11.2 billion SEK, representing an 83% premium. The transaction was successfully completed in September.

Calliditas’ journey underscores a few critical success factors:

• Innovative Approach: Applying an established molecule in a novel way to address a significant unmet need.
• Financially Savvy: Effective fundraising to fuel growth and operations.
• Regulatory Acumen: Successful navigation of regulatory pathways to achieve approvals.
• Strategic Partnerships: Selling regional rights strategically to secure cash resources, while ensuring focus on key markets.

In reflecting on the journey and the exit, Peter Wolpert, CEO at Industrifonden, noted, “Industrifonden’s involvement was not just about financial investment but also providing active support in the early phases to enable strategic growth and development. The success of Calliditas demonstrates our long-term commitment to supporting high-potential innovations and companies.”

Calliditas CEO, Renée Aguiar-Lucander, comments, “The early and continuous support from Industrifonden has been instrumental in our journey. Their commitment and support as long-term investors have been pivotal in achieving our clinical and commercial success.”